Highlights
-
•
While multiple studies have demonstrated the safety of DCB, the optimal duration and type of antiplatelet therapy following DCB treatment remain unclear.
-
•
The decision on the optimal duration and type of antiplatelet drugs after DCB treatment should depend on the clinical and angiographic characteristics of each patient.
-
•
DCB may offer several advantages over DES, including a shorter duration of DAPT or the possibility of using a SAPT in selected cases, which carries a lower risk of bleeding, particularly in high-risk patients.
Abstract
Drug eluting stents (DES) are the standard treatment for percutaneous coronary intervention (PCI) in real-world clinical practice. However, the implantation of DES is associated with significant limitations, such as the development of neo-atherosclerosis and a persistent risk of stent failure during mid- and long-term follow-up. Currently, dual antiplatelet therapy (DAPT) after stent implantation is required for at least 1 month, with the majority of patients receiving DAPT treatment for 6 to 12 months, which carries an inherent increased risk of bleeding complications. Drug-coated balloons (DCB) are alternative to DES in some lesion settings, such as in-stent restenosis or small coronary artery disease (CAD), with promising initial results also in other clinical or lesion settings, such as acute coronary syndromes, de novo lesions and complex CAD. Although the safety of DCB has been shown in several studies, the optimal regimen and duration of antiplatelet therapy (APT) after DCB treatment remain unclear. In this study, we review the current evidence on protocol-mandated antiplatelet therapies across DCB studies and propose an antiplatelet algorithm for patients with CAD treated with DCB.
Graphical abstract
Abbreviations
ACS, acute coronary syndrome; APT, antiplatelet therapy; BMS, bare-metal stents; BARC, Bleeding Academic Research Consortium; CAD, coronary artery disease; CCS, chronic coronary syndrome; CTO, chronic total occlusion; DCB, drug-coated balloon; DES, drug eluting stents; DAPT, dual antiplatelet therapy; HBR, high bleeding risk; ISR, in-stent restenosis; LAD, left anterior descending; LLL, late lumen loss; MACE, major adverse cardiovascular events; MB, main branch; MI, myocardial infarction; PCB, paclitaxel coated balloon; PCI, percutaneous coronary intervention; POBA, plain old balloon angioplasty; RCT, Randomized controlled trial; SAPT, single antiplatelet therapy; SB, side branch; TLR, target lesion revascularization.
Introduction
Since the first procedure performed by A. Gruentzig in 1977, percutaneous coronary intervention (PCI) has undergone continuous development, evolving from plain old balloon angioplasty (POBA) to metallic platforms, including bare-metal stents (BMS) and, later, drug-eluting stents (DES). ,, Antiplatelet therapy (APT) following PCI plays a pivotal role in minimizing the risk of early and late/very late stent thrombosis. , However, prolonged dual APT (DAPT) is associated with high rates of bleeding complications.
Moreover, the growing complexity of coronary lesions treated with PCI contributes to a persistently elevated thrombotic risk post-intervention, while the aging population and the rising burden of comorbidities further increase the risk of hemorrhagic events. , Therefore, the implementation of dedicated DAPT strategy, balancing individual ischemic and hemorrhagic risks following PCI, is essential for improving long-term outcomes. Over the past three decades, tailored DAPT regimens, often with shorter duration, have been validated based on patient and lesion characteristics. In parallel, technological advancements in stent platforms and device design have also been introduced to improve the outcomes of PCI. ,
Drug-coated balloons (DCBs) have emerged a valuable alternative to DES. These semi-compliant balloons, composed of polyurethane and nylon, deliver antiproliferative drugs via a lipophilic matrix to the target arterial wall.
Current evidence suggest that DCBs may promote faster endothelial healing and may reduce the risk of stent-related thrombosis and neoatherosclerosis compared to DES implantation. , The culprit site in acute coronary syndrome (ACS) is a negative predictor of endothelial coverage after DES implantation, with complete coverage observed in only 6.9% of cases at 90 days. In contrast, recent preclinical data show that DCB treatment achieves substantially greater endothelial healing, with endothelial coverage exceeding 96% within 28 days. Consequently, DCB therapy may enable tailored and less intensive APT regimens and, in selected cases, may even permit a single APT (SAPT) regimen after PCI.
However, despite expert consensus recommendations, the optimal APT strategy following DCB angioplasty has not yet been investigated. Initial randomized controlled trials (RCTs) employed 12 months of DAPT in ACS and 1 to 6 months in chronic coronary syndrome (CCS). ,,,,,, In the REC CAGEFREE I trial, 60.5% of patients treated with DCB were still on DAPT at 12 months. Only recently has there been growing interest in minimizing APT duration after PCI with DCB, and the very recent REC CAGEFREE II trial is currently the only RCT that has specifically investigated the role of short-duration APT following DCB angioplasty. The aim of this paper is: (1) to summarize the antiplatelet agents currently available in clinical practice; (2) to review the current evidence on the regimen and duration of APT following PCI with DCB across various clinical and angiographic settings; (3) to propose an antiplatelet algorithm after DCB treatment.
Overview of DCB technologies and clinical applications
The key components of DCB technology comprise a semi-compliant balloon, an excipient and an antiproliferative drug on the balloon surface. ,
Contemporary DCB leverages two main antiproliferative agents, with distinct mechanisms of action. Paclitaxel interferes with microtubule assembly, irreversibly halting cell cycle progression and exerting cytotoxic effects. In contrast, sirolimus acts as a cytostatic agent, by inhibiting the mammalian target of rapamycin pathway to prevent cell proliferation. Although sirolimus has lower lipophilicity, it offers a broader therapeutic window, and a wider safety margin compared with paclitaxel. Indeed, some evidence has reported concerns regarding paclitaxel-related smooth-muscle cell necrosis, distal embolization, and systemic drug diffusion. Comparative observational studies and RCT across various settings have demonstrated comparable efficacy between paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs) in terms of clinical outcomes. ,,,, However, some reports have described more favorable angiographic results with PCBs, particularly with regard to late vessel enlargement.
Originally developed for the treatment of in-stent restenosis (ISR), DCBs have since been evaluated for use in de novo coronary artery disease (CAD). The recent patient-level ANDROMEDA meta-analysis demonstrated the superiority of DCB over DES in small-vessel CAD, showing a significant reduction in major adverse cardiovascular events (MACE) at 3 years. As experience and evidence grow, DCB use has expanded into more increasingly complex anatomical and clinical settings, including acute coronary syndromes (ACS), heavily calcified lesions, chronic total occlusions (CTOs), and high-risk patient populations, such as elderly and high bleeding risk (HBR) patients. ,, DCBs may represent a tailored revascularization strategy for HBR patients, given the opportunity to reduce metal burden and shorten the duration of DAPT. However, current evidence remains limited.
Pharmacology of antiplatelet drugs
Antiplatelet agents are central to preventing atherothrombotic events in PCI. Two main classes are used in clinical practice:
-
•
Aspirin (acetylsalicylic acid) : An irreversible cyclooxygenase-1 (COX-1) inhibitor that suppresses thromboxane A₂-mediated platelet aggregation.
-
•
P2Y₁₂ receptor antagonists : These include clopidogrel, prasugrel, and ticagrelor. Compared to clopidogrel, prasugrel and ticagrelor provide faster, more potent and consistent platelet inhibition, and are associated with a greater reduction in thrombotic events, albeit at the cost of increased bleeding risk.
Prasugrel and ticagrelor are recommended as first-line therapies for patients with acute coronary syndrome (ACS). In CCS) clopidogrel remains the standard P2Y₁₂ inhibitor.
Antiplatelet therapy after DCB angioplasty-data from the literature
Growing evidence has explored various APT regimens following DCB angioplasty in recent years. , The majority of available evidence stems from observational clinical studies comparing DCB with DES across a range of clinical contexts and CAD settings. Earlier investigations were not designed to evaluate APT strategies and focused primarily on ischemic endpoints, as the main objective at that time was to prevent ischemic recurrences. More recent research has begun to incorporate bleeding outcomes as well, reflecting the increasing proportion of complex patients with multiple comorbidities.
Emerging observational data from studies adopting progressively shorter APT durations, and preliminary experiences with SAPT after DCB angioplasty, suggest that a minimized APT strategy may be prognostically relevant, as it appears to reduce bleeding events without increasing ischemic recurrences. ,,, Nonetheless, APT duration should be individualized based on clinical presentation and lesion characteristics. ,
Given the clinical importance of this topic, randomized trials directly comparing different DAPT strategies after DCB angioplasty are only now beginning to emerge, and the search for the optimal APT regimen remains ongoing.
In-stent restenosis lesions
Kufner et al reported that approximately 20% to 30% of patients require target lesion revascularization (TLR) within 10 years following stent implantation. Data on APT regimen following DCB PCI in ISR are scant and most relevant RCT used different APT regimens. In the RIBS-IV trial, patients treated with paclitaxel-coated balloon (PCB) received DAPT with aspirin and clopidogrel for 3 months, followed by aspirin monotherapy, whereas those in the DES arm received 12 months of DAPT. At 1 year, three cases of definitive vessel thrombosis were reported, two in the DCB arm and one in the DES arm. In contrast, the DARE trial involved 278 patients with ISR (both BMS and DES-ISR), who received 12 months of DAPT, regardless of whether they were treated with PCB or DES. At 1 year, no cases of vessel thrombosis were reported, and bleeding events were not recorded. In the more recent AGENT IDE RCT, DAPT was prescribed for at least 1-month post-procedure, regardless of randomized assignment, followed by SAPT until 12 months. At 12 months, 78% of patients were on DAPT, with no differences between the two groups. Among those on SAPT, 57% were on clopidogrel and 43% on aspirin. Unfortunately, none of these studies reported data on bleeding-related adverse events ( Table 1 ).
Table 1
Current evidence on APT regimens following DCB angioplasty in ISR
| Study | Study type | Study population | DCB type | Lesion type | Antiplatelet type and duration |
|---|---|---|---|---|---|
| RIBS IV | multicenter, open-label, controlled, randomized clinical trial | 309 patients with DES-ISR allocated to DCB ( n = 154) or DES ( n = 155). | SeQuent Please | DES-ISR of lesion <30 mm and in vessels>2 mm of diameter | 3 mo DAPT (aspirin + clopidogrel) followed by aspirin indefinitely |
| DARE | Prospective multicenter randomized trial | 278 patients (56% DES-ISR) randomized DCB ( n = 141) or DES ( n = 137). | SeQuent Please | ISR all lesion types, including ostial, left main, bifurcation, chronic total occlusion, grafts. | 12 mo DAPT followed by life-long aspirin. |
| AGENT IDE | Multicenter, randomised, open-label, non-inferiority study | 125, ACS and CCS | Agent and POBA | ISR of lesion <28 mm in length | 3 mo DAPT followed by aspirin monotherapy |
ACS , Acute coronary syndrome; CCS , Chronic coronary syndrome; DAPT , Dual antiplatelet therapy; DCB , Drug Coated Balloon; DES , drug eluting stents; ISR , In-stent restenosis.
Small/mid-sized de novo coronary vessels
The BELLO was a landmark investigation comparing PCB angioplasty ( n = 90, with bailout BMS if needed), and DES ( n = 92) for small-vessel CAD. In this study, investigators employed the following DAPT regimen: 1 month for PCB, 3 months for DCB plus BMS, and 12 months for paclitaxel DES. However, the occurrence of hemorrhagic events was not addressed.
In the large BASKET-SMALL 2 trial, 382 patients were treated with the SeQuent Please PCB, while 376 patients received either a paclitaxel- or everolimus-DES. For patients CCS, DAPT durations were 1 month in the DCB arm and 6 months in the DES arm. In patients presenting with ACS, a 12-month DAPT regimen was applied irrespective of treatment strategy. For those requiring bailout stenting, DAPT was administered for 3 months with BMS and 6 months with DES. At both 12- and 36-month follow-ups, MACE rates were comparable between the treatment groups. , Of interest, at 3 years, the rate of major bleedings was numerically lower in the DCB group (2% vs 4%, P =.088), likely reflecting the short DAPT duration (aspirin and clopidogrel) (median 209 vs 336 days) compared to DES.
The PICCOLETO II RCT randomized patients with de novo lesions in vessels <2.75 mm to receive either Elutax SV PCB (AR Baltic, Germany) or everolimus DES. In CCS patients, DAPT was prescribed for ≥30 days post-DCB and for 6 to 12 months post-DES. All patients with ACS received a 12-month prescription of DAPT. No major bleeding events were reported at 1 year in both groups. At 3 years, MACE was significantly lower in the DCB group (10.8% vs 20.8%, P =.046), primarily driven by a reduction in MI and acute vessel occlusion. ,
The RESTORE SVD China study reported comparable outcomes between the Restore DCB (Cardionovum, Germany) and second-generation RESOLUTE Integrity DES in patients with vessel diameter ≥2.25 mm and ≤2.75 mm. DAPT was recommended for a minimum of 6 months. During the 12-month follow-up, no significant differences in DAPT duration were observed between the DCB and DES groups (91.4% vs 94.7%), likely reflecting the high prevalence of unstable angina, , and bleeding events were not recorded ( Table 2 ).
Table 2
Current evidence on APT regimens following DCB angioplasty in small-vessel disease
| Study | Study type | Study population | DCB type | Lesion type | Antiplatelet type and duration |
|---|---|---|---|---|---|
| BELLO | Prospective, multicenter, single-blinded, controlled clinical study | 182, both ACS and CCS patients | IN.PACT Falcon (Invatec-Medtronic- US), Taxus Libertè, Boston Scientific, Massachusetts, US) | De novo small vessel disease (<2.8 mm) |
1 mo of DAPT (aspirin + clopidogrel) (3 mo in DCB+BMS)
+ lifelong aspirin |
| BASKET-SMALL 2 | Prospective, randomized, multicenter, open-label, non-inferiority study | 758, both ACS and CCS patients | SeQuent Please (B. Braun, Germany) | De novo small vessel disease (<3.0mm) |
|
| PICCOLETO II | Investigator- initiated, prospective, randomized, multicenter, open-label clinical trial | 232, both ACS and CCS patients | Elutax SV/Emperor (Aachen Resonance, Germany) | De novo small vessel disease (<2.75mm) |
|
| RESTORE. | prospective, randomized, open-label, multicenter trial | 230, both ACS and CCS patients | Restore (Cardionovum) | De novo small vessel disease (≥2.25 and ≤2.75) | At least 6 mo of DAPT |
ACS , acute coronary syndrome; BMS , bare-metal stents; CCS , chronic coronary syndrome; DAPT , dual antiplatelet therapy; DCB , drug coated balloon.
Large de novo coronary vessels
Initial evidence on the association between DAPT duration and ischemic/hemorrhagic outcomes following DCB angioplasty has been emerging in recent years, particularly in de novo lesions with a reference vessel diameter >3 mm. Some single-arm observational studies have reported that short DAPT following DCB angioplasty is associated with low rates of ischemic adverse events at follow-up. A large-scale, multicenter prospective study conducted by Rosenberg et al , confirmed the efficacy of DCB-only treatment in both large and small vessels. In this study, a 1-month DAPT regimen was recommended for patients treated with DCB only, while those requiring bailout stenting were prescribed a minimum of 6 months of DAPT. The mean DAPT duration was 2.7 ± 1.6 months for large vessels and 2.8 ± 1.6 months for small vessels, with an overall incidence of vessel thrombosis below 1%.
A retrospective analysis further supported the safety of a 1-month DAPT strategy following elective DCB-only angioplasty in 303 patients, of whom 86.1% had de novo lesions and 56.5% had non-small vessel CAD (defined as ≥3 mm in diameter). Over a 6-month follow-up period, no cases of lesion thrombosis, target vessel MI, TLR, or cardiac death were reported.
The landmark DEBUT trial demonstrated the superiority of DCB over BMS in HBR patients, all of whom received a 1-month DAPT regimen with aspirin and clopidogrel and 6-month aspirin in those with ACS on oral anticoagulation therapy. In this study, 64% of patients in the DCB group were treated with balloons ≥3 mm in diameter, and no cases of stent thrombosis were reported. At 9 months, the DCB group showed a significantly lower rate of MACE (1% vs 14%), driven mainly by reductions in TLR (0% vs 6%, P <.0001) and non-fatal MI (0% vs 6%, P <.0001). In addition, the rate of bleeding events was very high, with no differences between DCB and BMS groups (13% vs 10%, P =.59).
Most recently, the REC CAGEFREE I trial enrolled 2,272 patients with de novo, non-complex CAD, who were randomized to treatment with either PCB or second-generation DES treatment. While the APT was not prespecified, the DCB group discontinued DAPT earlier than the DES group (at 12 months, 60.5% of patients in the DCB group were on DAPT compared to 70.8% in the DES group) and showed a numerically lower incidence of Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding events (1.4% vs 2.4%). However, no dedicated APT regimen was pre-specified in the two groups, and the authors did not perform a post hoc analysis to identify specific patient or lesion subgroups in which the lower bleeding event rates observed in the DCB group, compared to DES, may have been more pronounced ( Table 3 ).
Table 3
Current evidence on APT regimens following DCB angioplasty in large vessels
| Study | Study type | Study population | DCB type | Lesion type | Antiplatelet type and duration |
|---|---|---|---|---|---|
| Rosenburg et al. | Prospective large-scale multicenter study | 234, ACS and CCS | SeQuent Please (B. Braun Melsungen AG) | 66.9% de novo CAD, mean reference vessel diameter 2.6 1 mm |
Half of the patients 1 mo DAPT
−2.7 ± 1.6 mo in large vessels vs 2.8 ± 1.6 mo in small vessels ( P =.583) |
| Corballis et al. | Retrospective cohort study | 303, only CCS |
39.6% SeQuent Please (B Braun Melsungen AG, Germany)
51.5% SeQuent Please NEO (B Braun Melsungen AG, Germany) 8.6% IN.PACT Falcon (Medtronic, Inc., Santa Rosa, CA) 0.3% DIOR (Eurocor GmbH, Germany). |
Both de novo and ISR lesions, 56.5% large vessels | 1 mo DAPT, followed by lifelong aspirin |
| REC CAGEFREE I | Randomized controlled trial |
2252,
ACS and CCS |
Swide DCB | Non-complex de novo CAD, 49.6% large vessels | At 12 mo, 26% were on SAPT |
ACS , acute coronary syndrome; CAD , coronary artery disease; CCS , chronic coronary syndrome; DAPT , dual antiplatelet therapy; DCB , drug coated balloon; ISR , in-stent restenosis; SAPT , single-antiplatelet therapy.
Bifurcation lesions
Bifurcation lesions pose a challenge to interventional cardiologists, often necessitating complex procedural strategies and being associated with suboptimal long-term outcomes. The latest recommendations from the European Bifurcation Club advocate a provisional stenting approach as first-line treatment, with the option to use a DCB for side branch (SB) treatment. However, data on DCB use in bifurcation lesions remain limited and often derives from small cohorts.
Bruch and colleagues conducted an observational study involving 127 patients with 130 bifurcation lesions. In patients treated exclusively with DCB (53.8% of cases), short DAPT was recommended: aspirin was continued lifelong, while clopidogrel was administered for 4 weeks post-procedure. At 12 months, DAPT was prescribed in 18.6% of DCB-only PCI and 71.9% of hybrid DCB/DES PCI.
In the recently published DCB-BIF RCT, patients treated with DCB ( n = 391) for severely compromised SB experienced a lower incidence of MACE compared to those treated with non-compliant balloons ( n = 393). All patients received 12 months of DAPT following PCI. Therefore, these studies employed heterogenous APT regimens, and none of them evaluated bleeding endpoints ( Table 4 ).
Table 4
Current evidence on APT regimens following DCB angioplasty in bifurcation lesions
| Study | Study type | Study population | DCB type | Lesion type | Antiplatelet type and duration |
|---|---|---|---|---|---|
| Schulz et al. | Retrospective study | 39 patients | SeQuent Please | De novo bifurcations with SB diameter >2 mm | At least 1-mo DAPT followed by aspirin monotherapy |
| DCB-BIF | multicenter, randomized controlled trial | 784 patients | SeQuent Please | True coronary bifurcation lesions with a severely compromised SB | 12-mo DAPT |
ACS , acute coronary syndrome; CCS , chronic coronary syndrome; DAPT , dual antiplatelet therapy; DCB , drug coated balloon; SB , side branch.
Chronic total occlusion lesions
Data on the performance of DCB in chronic total occlusions (CTOs) remain limited, with no RCTs currently available. A recent meta-analysis by our group showed that DCB-based PCI is associated with similar clinical outcomes compared to second-generation DES PCI in CTOs. To date, only two single-arm studies have specifically investigated DCB angioplasty in CTOs, while reporting data on DAPT duration, showing encouraging angiographic and clinical results with relatively short durations of DAPT.
Acute coronary syndrome
ACS represents the most severe clinical manifestation of ischemic heart disease, often associated with pancoronary vulnerability, with high burden of non-culprit vulnerable plaques and an approximately 40% higher risk of bleeding complications following PCI compared to CCS.
In recent years, both RCTs and observational studies have evaluated the safety and efficacy of DCB angioplasty versus DES in ACS populations. However, these studies focused only on ischemic endpoints. Moreover, most studies employed 12-month DAPT following PCI in both groups and none of the studies reported data on bleeding-related adverse events, leaving a gap in current knowledge.
Nonetheless, as the bleeding risk has been shown to exceed ischemic risk after the first 2 weeks post-PCI, multiple strategies have been developed to reduce DAPT intensity in ACS patients treated with DES. These include shortening DAPT duration and de-escalating from potent P2Y₁₂ inhibitors (eg, ticagrelor or prasugrel) to clopidogrel, with promising outcomes in terms of both safety and efficacy.
The recent REC CAGEFREE II trial was the first to evaluate dedicated APT strategies in patients with ACS treated with PCB. A total of 1,948 patients were randomized 1:1 to either a stepwise DAPT de-escalation regimen (aspirin plus ticagrelor for 1 month, followed by ticagrelor monotherapy for 5 months, and then aspirin monotherapy for 6 months) or the standard DAPT regimen (aspirin plus ticagrelor for 12 months). At 12-month follow-up, the de-escalation strategy was non-inferior to standard 12-month DAPT in terms of net adverse clinical events (8.9% vs 8.6%). Notably, the de-escalation group experienced a significantly lower rate of BARC type 3 or 5 bleeding events (0.4% vs 1.6%, P =.008), with comparable incidence of the device-oriented composite endpoint (cardiovascular death, target vessel MI, and TLR) between groups (5.2% vs 4.6%, P =.57). However, no comparisons between different durations of DAPT or strategies to minimize exposure to specific antiplatelet agents have been conducted ( Table 5 ).
Table 5
Current evidence on APT regimens following DCB angioplasty in acute coronary syndrome
| Study | Study type | Study population | DCB type | Lesion type | Antiplatelet type and duration |
|---|---|---|---|---|---|
| REC CAGEFREE II | Randomized controlled trial | 1948, ACS | Sequent Please ( n = 327), RESTORE ( n = 513), Bingo ( n = 523), Swide ( n = 288), Vesselin ( n = 242), others ( n = 55) | 82% de novo CAD, 39% large vessels | -Stepwise DAPT de-escalation: 1-mo aspirin + ticagrelor followed by 5-mo ticagrelor monotherapy, followed by aspirin monotherapy—Standard 12-mo DAPT (aspirin + ticagrelor) |
ACS , acute coronary syndrome; CAS , coronary artery disease; CTO , chronic total occlusion; DAPT , dual antiplatelet therapy; DCB , drug coated balloon.
Antiplatelets after DCB in high bleeding risk patients
Short DAPT studies
HBR patients represent a particularly compelling population for the use of DCB. A retrospective all-comer study, which included 52% of HBR patients, demonstrated the safety and feasibility of short-term DAPT following DCB treatment in both CCS and ACS (34% multivessel CAD, left anterior descending artery (LAD) was the most common target vessel (41%). Mean DAPT duration was 2.8 months for CCS and 3.3 months for ACS. The rates of MACE were 9.8% and 14.8% at 12 and 24 months, while TLR were 2.1% and 3.1%. Additionally, the rates of BARC 2 to 5 bleeding events were 5.9% and 7.5% at 12 and 24 months, respectively.
The aforementioned DEBUT trial further supported the role of DCBs in HBR patients. In this study, 208 patients with de novo coronary lesions, either in native arteries or saphenous vein grafts, were randomized to receive PCB or BMS, with all patients treated with 1-month DAPT. At 9-month follow-up, the rate of MACE was significantly lower in the DCB group (1% vs 14%).
In parallel, studies involving stent implantation have consistently demonstrated the superiority of second-generation DES over BMS in HBR populations. Of interest, the 12-month TLR rate after DES angioplasty followed by short-duration DAPT ranged from 1.8% to 2.3%, , which is consistent with reports from DCB studies. However, RCTs directly comparing DCB and second-generation DES in HBR patients are currently lacking, highlighting a critical gap in the existing literature.
Single antiplatelet therapy studies
Retrospective data have shown promising results for the use of SAPT following DCB treatment in HBR patients. Räsänen and colleagues evaluated a cohort of 172 patients who received SAPT after DCB angioplasty. The population included 58% with ACS, 87% classified as HBR, 65% on concomitant anticoagulation therapy, and 96% with de novo coronary lesions; notably, 58% had large vessel CAD, 95.7% had de novo lesion and the LAD was the most frequently treated vessel (39.7%). Moreover, 19.0% of lesions were calcified and 20.3% required rotational atherectomy. PCB were the most devices used (97.1%), while SCB were used in only 2.9% of patients. Approximately half of the patients received periprocedural DAPT, which was discontinued at hospital discharge. At 1-year follow-up, MACE occurred in 1.4% of CCS patients and 7.1% of ACS patients. 69.8% were discharged on aspirin and 21.5% on clopidogrel. No cases of acute vessel closure were reported, and BARC type 2 to 5 bleeding events were observed in 10.5% of patients.
Comparable results were reported by Cortese et al, which analyzed 107 HBR patients who underwent DCB-only PCI with SAPT initiated at the time of intervention (65% on clopidogrel, 35% on aspirin). CCS was the most frequent clinical presentation in the SAPT group (87%); 9% of target lesions were CTOs and the mean reference vessel diameter was 2.68 mm. Furthermore, a non-flow limiting dissection was angiographically observed at the end of the procedure in 47% of cases. Outcomes were compared with a control cohort of 1,110 patients treated with DAPT but not considered HBR. At 12 months, MACE was 10% in DAPT and 9% in SAPT (OR 1.03, 95% CI: 0.53-1.98). However, BARC type 2 to 5 bleeding events were more frequent in the DAPT group (OR 0.80, 95% CI: 0.38-0.98). No acute MIs or vessel occlusions were reported in either group during the follow-up period.
The EASTBOURNE study, an investigator-initiated trial, evaluated the outcomes of the first sirolimus-coated balloon (Magic Touch, Concept Medical, USA) in an all-comer population of 2.123 patients with 2.440 treated lesions. Patients with CCS received 1 month of DAPT, while those with ACS were prescribed 6 to 12 months of DAPT. A subset of 113 patients were managed with SAPT. De novo lesions were the most frequently treated lesions (56%) in both the SAPT and DAPT groups, with no differences observed in reference vessel diameter (mean 2.6 mm) and lesion length (mean 19 mm). However, patients in the DAPT were more likely to undergo multivessel PCI (43% vs 27%, P =.001). At 12-month follow-up, MACE rates were comparable between SAPT and DAPT groups (11.2% vs 8.9%, P =.519), while the SAPT cohort experienced more BARC type 2 to 5 bleeding events (2.9% vs 0.6%, P =.027), probably due to the higher baseline bleeding risk. These findings are consistent with the OPTICA (Optical Coherence Tomography–Guided PCI with Single Antiplatelet Therapy) study, which evaluated the clinical performance of P2Y12 inhibitor monotherapy (either ticagrelor or prasugrel) following PCI with new-generation DES. The study enrolled 35 patients presenting with ACS. Within 6 months, the primary ischemic endpoint occurred in 4.0% of patients, with no cases of stent thrombosis or spontaneous MI. The primary bleeding endpoint was observed in 9.3% of patients. Notably, there is currently no consensus regarding the optimal antiplatelet agent for SAPT, whether initiated immediately after DCB angioplasty or following a short course of DAPT. A patient-level meta-analysis of five RCTs ( n = 16,117) demonstrated the superiority of P2Y₁₂ inhibitor monotherapy over aspirin in reducing major adverse cardiac and cerebrovascular events (HR: 0.77), without a significant increase in major bleeding after DES implantation. These findings have been confirmed by a very recent meta-analysis, which showed reduced incidence of net adverse clinical events and major bleeding with P2Y₁₂ inhibitor monotherapy compared to aspirin. However, RCTs comparing clopidogrel and aspirin monotherapy following DCB PCI are lacking. Treatment decisions should be individualized, taking into account clinical and anatomical factors, as well as considerations such as aspirin-related gastrointestinal side effects and the potential for clopidogrel resistance in certain patients.
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
